Interaction Study in Patients With Pulmonary Hypertension and Stable Treatment of Sildenafil 20 mg TID

Interaction Study to Investigate Safety, Tolerability, Pharmacokinetics and the Impact on Pulmonary and Systemic Hemodynamics of Single Doses of 0.5 and 1 mg of BAY 63-2521 in Patients With PAH and Stable Treatment of Sildenafil 20 mg TID in a Non-randomized, Non-blinded Design

This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of BAY63-2521 in patients with pulmonary hypertension and stable treatment of sildenafil 20 mg.

Inclusion Criteria:

• Patients with pulmonary hypertension stable for the last 6 weeks
• Treated with Sildenafil 3 × 20 mg
• Undergoing routine invasive diagnostics.

Exclusion Criteria:

• Pre-existing lung disease other than pulmonary arterial hypertension,
• Acute or severe chronic left heart failure,
• Severe coronary artery disease,
• Uncontrolled arterial hypertension;
• Congenital or acquired valvular or myocardial disease except acquired tricuspid valve insufficiency due to pulmonary hypertension,
• Systolic blood pressure < 100 mmHg, heart rate < 55 bpm or >105 bpm, PaO2/FiO2 < 50 mmHg,
• PaCO2 > 55 mmHg,
• Severe hepatic insufficiency,
• Severe renal insufficiency,
• Administration of strong CYP3A4 inhibitors or inductors